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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Thermal Regulating
510(k) Number K261437
Device Name Mistral-Air® Warming System
Applicant
The Surgical Company International B.V., doing business as TSC Life
Paalbergweg 3
Noord-Holland
Amsterdam,  NL 1105 AG
Applicant Contact Gianpaolo Soares
Correspondent
The Surgical Company International B.V., doing business as TSC Life
Paalbergweg 3
Noord-Holland
Amsterdam,  NL 1105 AG
Correspondent Contact Gianpaolo Soares
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received04/30/2026
Decision Date 08/07/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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